Safety and Effectiveness of Siddha Sastric Medicines for the Management of Covid-19

A prospective, non-randomised, single arm observational study to access the safety and effectiveness of Siddha Sastric Medicines â?? Fixed Regimen intervention in prevention of COVID-19 disease progression of severity from COVID-19 Positive asymptomatic, mild or moderate to critical with reference to the Siddha guidelines of COVID-19 management, Ministry of AYUSH, Govt. of India at a Home Quarantine Chennai Containment Zone

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026470

Enrollment

200

Registered

2020-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Siddha Medicines in fixed regimen: Kaba Sura Kudineer Chooranam â?? Decoction â?? Two times daily before 30 min of meals for 14 days, Adathodai Manapagu â?? 10 ml â?? Three times dail

Eligibility

Inclusion criteria

Inclusion criteria: 1. COVID -19 Positive as determined by RT-PCR or other approved commercial or public health assay 2. Willing to provide written/digital informed consent. 3.COVID - 19 Positive with no clinical signs 4.COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever 5.COVID - 19 Positive with moderate symptoms â?? Fever with cough, breathlessness but respiratory rate

Exclusion criteria

Exclusion criteria: 1. Pregnant and Lactating females 2. COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation less than 94% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure 3. Chronic Renal Failure requiring dialysis (eGFR 4. Known cases of uncontrolled Diabetes ( >9% HbA1c) 5. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 6. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. 7. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy 8. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. 9. Subjects having a past history of allergy to any medicine that is part of the Siddha intervention. 10. Subjects with bleeding disorders and severe anaemia(Hb -

Design outcomes

Primary

Measure	Time frame
1.RT-PCR will be the gold standard used to assess sero conversion - Positive to negative which is the main outcome of this study. This will be used to establish the effect of the intervention. To support this, reduction in the severity of disease and reductions of symptoms will be documented. 2.Reduction in severity of the disease will be measured using Immune Status Questionnaire (ISQ). 3.Reductions of symptoms will be documented using case report form Timepoint: 14 days	—

Measure

Time frame

1.RT-PCR will be the gold standard used to assess sero conversion - Positive to negative which is the main outcome of this study. This will be used to establish the effect of the intervention. To support this, reduction in the severity of disease and reductions of symptoms will be documented. 2.Reduction in severity of the disease will be measured using Immune Status Questionnaire (ISQ). 3.Reductions of symptoms will be documented using case report form Timepoint: 14 days

—

Secondary

Measure	Time frame
1. Recovery without Hospitalization 2. Adverse events, if anyTimepoint: 14 days	—

Countries

India

Contacts

Public ContactDr V THANIGAVELAN

State Licensing Authority (IM)

pitchiahkumar@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026